FDA UDI
In Commercial Distribution
🇺🇸 United States
COPALITE SNAP BOND
DI: 00850015110313
·
Model: 4047
·
TEMREX CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- COPALITE SNAP BOND
- Primary DI
- 00850015110313
- Version / Model
- 4047
- Company Name
- TEMREX CORPORATION
- Labeler DUNS
- 012072823
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-02-20
- Public Version
- 3
- Public Version Date
- 2023-04-03
- Public Version Status
- Update
- Public Device Record Key
- d966a6d3-23c5-487a-b24e-c3ae6e3e0dae
Device Description
DENTIN BONDING ADHESIVE
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KLE | Agent, Tooth Bonding, Resin | Dental | 872.3200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62390 | Ceramic dental inlay adhesive solution | A solution intended to be applied to a ceramic dental inlay (indirect restorative) prior to cementation within the tooth structure to improve adhesion to the cement/luting agent. The inlay is often submerged and heated in the coating solution which typically includes aluminium ions whereby a layer of aluminium oxide forms on the inlay surface. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850015110313 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K915511 | 000 |